PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035

FDA device recall Z-0876-2023 · posted 2023-01-04 · Open, Classified

Recall details

Recalling firm

Biomerieux Inc

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Action taken

Biomerieux sent a FIELD SAFETY CORRECTIVE ACTION notice to the US subsidiary on 11/09/2022 by email. The notice requested the subsidiary identify their customers and issue an URGENT FIELD SAFETY NOTICE which explains the problem and request the following actions: "1. Confirm this letter has been distributed to and reviewed by all appropriate personnel within your organization. 2. Check your inventory for any of the impacted products (reference Table 1) associated with local shipments. 3. Stop using and scrap any remaining impacted products in your inventory. a. Request product replacement or credit for the destroyed product. b. Document the quantity destroyed in the Product Information section of the attached Acknowledgement Form. 4. Please store this letter with your bioMrieux documentation. 5. Complete the attached Acknowledgement Form and return it to your local bioMrieux representative as soon as possible." The customer notices were sent by FedEx Overnight Letter on 18 NOV 2022.

Root cause

Storage

Status

Open, Classified

Product code

JSO

Quantity affected

100 units

Distribution

US Nationwide distribution.

Date initiated

2022-11-09

Date posted

2023-01-04

Location

Hazelwood, MO