The Recall Desk

Manufacturer

Remel Inc.

86 recalls in our database name Remel Inc. as the manufacturing or recalling firm.

What the numbers show

Total
86
Critical
1
Severe
10
Most recent
2026-07-08

Of the 86 recalls from Remel Inc. we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (12%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–86 of 86

  • HighFDA (Devices)·Z-0538-2014·2013-12-25

    Remel Inc. Recalls Streptex Latex D Reagent for False Negative Results

    Remel Inc. is recalling 109 kits of Streptex Latex D reagent because the product may produce weak or false negative test results for streptococcal group D.

    Product
    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2014·2013-12-25

    Remel Inc Recalls Streptex Kits Due to Potential False Negative Results

    Remel Inc is recalling 768 Streptex kits because they may produce weak or false negative test results for Streptococcal grouping.

    Product
    Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0530-2014·2013-12-25

    Remel RapID Yeast Plus System Recalled for Mislabeled Reagents

    Remel Inc is recalling 150 kits of the RapID Yeast Plus System because the labels for Reagent A and Reagent B were reversed.

    Product
    remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0528-2014·2013-12-25

    Remel Recalls Oxoid Ciprofloxacin Test Discs Due to Labeling Error

    Remel Inc is recalling Oxoid Ciprofloxacin test discs because boxes labeled CIP5 may contain AMP5 cartridges.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2081-2013·2013-09-04

    Remel Recalls Oxoid Nitrofurantoin Antimicrobial Susceptibility Test Discs

    Remel Inc is recalling specific lots of Oxoid Nitrofurantoin test discs because they may provide false susceptibility results.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test me
    Category
    Medical Device
    Distribution
    17 states
  • LowFDA (Devices)·Z-1962-2013·2013-08-21

    Remel Flu A&B Control Swabs Recalled for Incorrect Quality Control Results

    Remel Inc is recalling Flu A&B Control Swabs because they may provide incorrect negative results for Flu A, potentially compromising quality control testing.

    Product
    Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Ki
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2013·2013-02-20

    Remel Lyophilized Growth Supplement Recalled for Microbial Contamination

    Remel Inc is recalling 10 units of a lyophilized growth supplement for Legionella testing due to potential low-level microbial contamination.

    Product
    The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0807-2013·2013-02-20

    Remel Xpect Clostridium difficile Toxin A/B Test Recalled for False Negatives

    Remel Inc is recalling 50 units of the Xpect Clostridium difficile Toxin A/B test kit due to a potential for false negative results.

    Product
    Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal sp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2013·2013-02-20

    Remel Xpect Clostridium difficile Toxin A/B Test Recalled for False Negatives

    Remel Inc is recalling specific lots of the Xpect Clostridium difficile Toxin A/B test kit due to a potential for false negative results.

    Product
    Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in huma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0808-2013·2013-02-20

    Remel Recalls Oxoid Cefoxitin Antimicrobial Susceptibility Discs Due to Insufficient Dose

    Remel Inc is recalling 23 units of Oxoid Cefoxitin Antimicrobial Susceptibility Discs because the cartridges may contain discs with an insufficient antibiotic dose.

    Product
    Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0790-2013·2013-02-13

    Remel Recalls Oxoid Aztreonam Antimicrobial Susceptibility Test Discs

    Remel Inc is recalling Oxoid Aztreonam test discs because some may lack antibiotic impregnation, potentially affecting test accuracy.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of
    Category
    Medical Device
    Distribution
    Distributed nationwide