Recall Z-0972-2012 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Siemens Healthcare Diagnostics
Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG) test system. Package of 25. Product Code 1760/ Catalog# 06484105). For in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens.
| Date | Feb 7, 2012 (initiated Dec 15, 2011) |
| Status | Terminated |
| Reason | A potential for false positive or increase in borderline results with patients and commercially available negative control material. |
| Root cause | Process control |
| Action | Siemens issued Overnight Mailings of Urgent: Recall Notices on December 15, 2011 for delivery beginning December 16, 2011 to Distributors and end users. Customer bulletin has been issued instructing customers to discontinue use of product and discard impacted inventory. Customers are to contact their distributor regarding credit for unused product. For technical questions contact Siemens Technical Solutions Center at 877-229-3711. |
| Quantity | 48,578 Kits (25 tests / kit) |
| Distribution | Worldwide Distribution -- US, Austria, Germany, Great Britain, Denmark, Norway, Sweden, Poland, Netherlands, Luxembourg, Belgium, Finland, France, Greece, Ireland, Italy, Portugal, Qatar, Saudi Arabia, Slovakia, Slovenia, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032563 | CLINITEST HCG PREGNANCY TEST Bayer Healthcare, LLC, Dec 23, 2003 |