Device recall
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
- Recall number
- Z-0107-2027
- Event id
- 99810
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
- Report date
- Oct 14, 2026
- Posted
- Oct 7, 2026
- Initiated
- Aug 25, 2026
- Center classification date
- Oct 7, 2026
- Product code
- JPH
- Device type
- Test, Erythrocyte Sedimentation Rate
- Reason
- 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).
- Root cause
- Process control
- Quantity
- 448400
- Code info
- Model/Catalog No. S-100 and S-1000; UDI-DI: N/A; Lot Number E1150A; Expiration Date 06/30/27
- Distribution
- Worldwide - US Nationwide distribution in the states and territory of AK, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the country of United Kingdom.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K840500
- Location
- Cortlandt Manor, NY, United States