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VIDAS RUB IgG (RBG), REF 30226 recallZ-0432-2022 · bioMerieux, Inc. · initiated Sep 22, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from bioMerieux, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

FDA root cause category: Nonconforming Material/Component

What the company is doing

For products with No remaining shelf life (taking into account the revised expiration date): - Identify impacted lots - Stop using the listed impacted lots - Destroy the remaining impacted lots in your inventory For products with remaining shelf life (taking into account the revised expiration date): - Identify impacted products and lots listed - Update product expiration date per your internal procedures of the remaining usable lots to meet the new revised expiration date specified in Table 1 - Continue product use until the revised expiration date. Consignees are asked to distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom you may have transferred affected product. Complete the Acknowledgement Form in Attachment A and return it to [email protected] or Fax to: (919) 620-3306 to confirm receipt of this notice.

Recall details

Recall number
Z-0432-2022
Status
Open, Classified
Initiated by the company
Sep 22, 2021
Recalling firm
bioMerieux, Inc.
Quantity
Three lots
Product code
LFX
Distribution
US Nationwide distribution.

Product description

VIDAS RUB IgG (RBG), REF 30226

Code information (models, lots, serial numbers)

UDI 03573026138585, Lot #: 1008694980, 1008700260, 1008828980

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 88797).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page