BD Vactuainer SST glass and plastic tubes recallZ-0052-05 · Becton Dickinson & Company · initiated Aug 20, 2004

Terminated All recalls posted in October 2004

Is my device affected?

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.
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.
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 tht this not a new recall. 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 adrenal gland function. The immunoassay results are high when

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-0052-05
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: K023075, K921806, K960250
Distribution: Worldwide distribution.

Product description

BD Vactuainer SST glass and plastic tubes.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

1 device cleared under K023075, K921806, K960250 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

BD Vacutainer® Serum Blood Collection Tubes 368660
Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
15 reports

Other products in the same recall event

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

Z-1603-05 · Terminated
BD Vacutainer Microtainer Serum tubes (with or without gel).

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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