Remel, Inc: Medical Device Recall in 2023 - (Recall #: Z-2038-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 31, 2023

Date Posted: July 5, 2023

Recall Number: Z-2038-2023

Event ID: 92444

Reason for Recall:

The test medium may not perform as intended.

Status: Ongoing

Product Quantity: 1,296 packs

Code Information:

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.

Distribution Pattern:

Distribution was made nationwide, including Puerto Rico. There was no foreign or military distribution.

Voluntary or Mandated:

Voluntary: Firm initiated