Recall Z-0107-2027
- Recall number
- Z-0107-2027
- Event number
- 99810
- Firm
- POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
- Firm FEI
- 1000119795
- Product code
- JPH
- Status
- Open, Classified
- Initiated
- 2026-08-25
- Posted
- 2026-10-07
- Root cause
- Process control
- 510(k) numbers
- K840500, K831195, K852554, K871076, K860899, K823368, K823761
Product#
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
Reason for Recall#
During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to a biological hazard (blood).