Z-2038-2023Class II

Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium...

Name: Z-2038-2023 Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium...
Creator: Remel, Inc
Published: 2023-05-31
License: https://open.fda.gov/license/

Remel Inc / initiated 2023-05-31 / Open, Classified

FDA source

Remel, Inc began a recall of Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use on 2023-05-31. FDA classified it as Class II and gives the reason as "The test medium may not perform as intended". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2038-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-31
Posted: 2023-06-29
Recalling firm: Remel Inc
Product: Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: The test medium may not perform as intended.
FDA root cause: Under Investigation by firm
Action: The firm issued recall letters dated 5/31/2023 via mail on 5/31/2023 that were flagged as URGENT: Deliver to Micro Lab. The letter provides the reason for the field action, risk to health, the product and distribution information, and actions to be taken by the customer. The actions included the consignee review reported results by an appropriate technical expert. The letter should be passed onto all who need to be aware within the consignee's organization or to any organization where the affected products have been transferred. An Acknowledgement Form was enclosed for return to the firm via email. The form is for the consignee to acknowledge receipt of the recall notice and that it is understood, and the information and required actions have been brought to the attention of all relevant users and executed. The deadline for returning the form is 6/30/2023.
Quantity in commerce: 1,296 packs
Distribution: Distribution was made nationwide, including Puerto Rico. There was no foreign or military distribution.
Product codes and lots: REF R04033 lot numbers and expiration dates: Lot 619859 Exp. 2023-03-23, Lot 629086 Exp. 2023-03-31, Lot 629087 Exp. 2023-03-31, Lot 631001 Exp. 2023-04-11, Lot 634496 Exp. 2023-04-18, Lot 635369 Exp. 2023-04-19, Lot 645950 Exp. 2023-05-11, Lot 648004 Exp. 2023-05-18, and Lot 651372 Exp. 2023-05-23. UDI-DI #00848838004476. REF R01503 lot numbers and expiration dates: Lot 623548 Exp. 2023-03-28, Lot 631958 Exp. 2023-04-12, Lot 641527 Exp. 2023-05-02, Lot 644542 Exp. 2023-05-09, and Lot 648125 Exp. 2023-05-16. UDI-DI #00848838001932.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2038-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2038-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29

Product code JSO

K892928Class IIHaemophilus Test Medium (Agar)Remel Co. / cleared 1989-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)