Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk,

FDA device recall Z-2038-2023 · posted 2023-06-29 · Open, Classified

Recall details

Recalling firm

Remel, Inc

Reason for recall

The test medium may not perform as intended.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JSO

Quantity affected

1,296 packs

Distribution

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

Date initiated

2023-05-31

Date posted

2023-06-29

Location

Lenexa, KS

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