Remel, Inc: Medical Device Recall in 2023 - (Recall #: Z-2531-2023)

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 TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora

Product Classification:

Class II

Date Initiated: August 14, 2023

Date Posted: September 20, 2023

Recall Number: Z-2531-2023

Event ID: 92880

Reason for Recall:

On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples

Status: Ongoing

Product Quantity: 139 units (13,900 tests)

Code Information:

UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated