Recall Z-0107-2027 ยท JPH Test, Erythrocyte Sedimentation Rate
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
| Date | Oct 7, 2026 (initiated Aug 25, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On August 26, 2026, URGENT PRODUCT RECALL letters were sent to customers. ACTIONS REQUIRED: 1. Examine your inventory and identify all Sediplast Westergren ESR tubes from Lot E1150A. 2. Immediately discontinue use and quarantine all unused tubes from the affected lot. 3. If affected product was distributed to other facilities or locations, immediately forward this notification to those recipients. 4. Contact Polymedco Technical Services to arrange replacement of the affected product and obtain instructions for its return or disposal. 5. Complete and return the enclosed Customer Recall Response |
| Quantity | 448400 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K840500 | SEDIPLAST Precision Technology, Inc., Feb 21, 1984 |