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BD Vacutainer Microtainer Serum tubes (with or without gel) recallZ-1603-05 · Becton Dickinson & Company · initiated Aug 20, 2004

Terminated All recalls posted in October 2004

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 Becton Dickinson & Company 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

"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and

FDA root cause category: Other

What the company is doing

The firm sent out a Technical Bulletin to all consignees of the specific instrument companies involved. Mailing initial were done 9/17/2004 and a revised mailing was sent 9/23/2004. Global communication will commense 10/5/2004.

Recall details

Recall number
Z-1603-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 20, 2004
Posted by the FDA
Oct 28, 2004
Recalling firm
Becton Dickinson & Company
Quantity
There is no linkage to any particular lot of BD product
Product code
JKA
FDA submissions
K771370, K931368, K940905, K991702, K002456
Distribution
Worldwide distribution.

Product description

BD Vacutainer Microtainer Serum tubes (with or without gel).

Code information (models, lots, serial numbers)

There is no linkage to any particular lot of BD product.

Other devices under the same FDA submission

9 devices cleared under K771370, K931368, K940905, K991702, K002456 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 30104).

Sources and updates

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