MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE - 365963

510(k) K991702

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

9 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK991702	Date28 Jul 1999Cleared	StatusActive

9 recalls · FDA

8 recalls, same reason
- Terminated Z-0059-2020 FDA Class II initiated 13 May 2019
- Terminated Z-0060-2020 FDA Class II initiated 13 May 2019
- Terminated Z-0056-2020 FDA Class II initiated 13 May 2019
- Terminated Z-0058-2020 FDA Class II initiated 13 May 2019
- Terminated Z-0054-2020 FDA Class II initiated 13 May 2019
- Terminated Z-0055-2020 FDA Class II initiated 13 May 2019
- Terminated Z-0061-2020 FDA Class II initiated 13 May 2019
- Terminated Z-0057-2020 FDA Class II initiated 13 May 2019
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
- Terminated Z-1603-05 FDA Unclassified (pre-2012) initiated 20 Aug 2004
"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

1 jurisdiction

United States — FDA 510(k) Active

510(k)