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US Biotek Laboratories
U.S. Biotek Laboratories LLC · Model 1.0 · UDI-DI 00860010959206
0
510(k) clearances
11
Adverse events
2
Recalls
46
Facilities
Description
Single-use convenient dried urine collection kit includes dry urine card and return packing for mailing to testing laboratory.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-09 | Medical Action Industries, Inc. 306 | An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027. |
| 2014-04-17 | Gen-Probe Inc | Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collect |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.