Remel Recalls
86 recalls on record · February 13, 2013 to July 8, 2026 · Medical Devices
Recalls by year
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 20, 2020Medical DevicesFDA
Remel Inc. recalls SWIN 2017 database, Model YSW4000
Hazard: Potential for out of range microbial results
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpo
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purp
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general pu
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/Dex, Hem, Vit K (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general pu
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purp
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpo
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general pur
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpos
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general pu
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpo
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for use in qualitative procedures as a general p
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general p
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
May 29, 2019Medical DevicesFDA
Remel Inc recalls Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general
Hazard: Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
September 19, 2018Medical DevicesFDA
Remel Inc recalls remel THIOGLYCOLLATE MEDIUM, REF 05152
Hazard: Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
September 19, 2018Medical DevicesFDA
Remel Inc recalls remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
Hazard: Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
September 19, 2018Medical DevicesFDA
Remel Inc recalls remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, RE
Hazard: Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
January 3, 2018Medical DevicesFDA
Remel Inc recalls Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in
Hazard: The serum may fail to agglutinate within the specified minimum reaction time.
December 13, 2017Medical DevicesFDA
Remel Inc recalls CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
Hazard: Product may have incorrect cation information detailed on the product label.
May 3, 2017Medical DevicesFDA
Remel Inc recalls Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood
Hazard: Confirmed complaint of surface contamination of Listeria monocytogenes.
March 15, 2017Medical DevicesFDA
Remel Inc recalls Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
Hazard: Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
June 15, 2016Medical DevicesFDA
Remel Inc recalls Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-la
Hazard: Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
December 23, 2015Medical DevicesFDA
Remel Inc recalls Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 d
Hazard: Antibiotic concentration may be insufficient which may result in incorrect test results.
August 19, 2015Medical DevicesFDA
Remel Inc recalls PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent f
Hazard: A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
August 19, 2015Medical DevicesFDA
Remel Inc recalls PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of be
Hazard: A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
July 1, 2015Medical DevicesFDA
Remel Inc recalls VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and re
Hazard: Use of the recalled product may result in false positive reports.
July 1, 2015Medical DevicesFDA
Remel Inc recalls VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and rec
Hazard: Use of the recalled product may result in false positive reports.
June 17, 2015Medical DevicesFDA
Remel Inc recalls Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates).
Hazard: Product may be contaminated with Listeria monocytogenes.
March 11, 2015Medical DevicesFDA
Remel Inc recalls Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the
Hazard: Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.