Recall Z-0107-2011 ยท CEW Radioimmunoassay, Parathyroid Hormone
Beckman Coulter Inc.
Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism
| Date | Oct 20, 2010 (initiated Mar 4, 2010) |
| Status | Terminated |
| Reason | The recall was initiated after Beckman Coulter confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA assay may not be achieved for lot numbers: 891198, 990980 and 991448. The kit lot numbers listed above passed the stability testing performed at 6 months, but failed the testing performed at 12 months. Therefore the affected I-PTH ELISA kit lots may produce falsely elevated patient r |
| Root cause | Other |
| Action | Beckman Coulter sent an URGENT: PRODUCT CORRECTIVE ACTION letter dated March 17, 2010 with attached Customer Response form to all customers who received Active I-PTH ELISA kits with the affected lot numbers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to: (1) Discontinue use of all materials provided with I-PTH ELISA kit lot numbers 891198, 990980 and 991448; (2) Review historical external quality control results to ensure the assay performance of these lots was within laboratory specifications. Retesting may be necessary if your l |
| Quantity | 70 kits |
| Distribution | Nationwide Distribution including the states of CA, CT, IA, IL, MI, NY, SC, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952199 | ACTIVE INTACT PTH ELISA Diagnostic Systems Laboratories, Inc., Jul 17, 1995 |