Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG) test system. P
FDA device recall Z-0972-2012 · posted 2012-02-07 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics
- Reason for recall
- A potential for false positive or increase in borderline results with patients and commercially available negative control material.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- 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
- Date initiated
- 2011-12-15
- Date posted
- 2012-02-07
- Date terminated
- 2015-03-30
- Location
- Tarrytown, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLINITEST HCG PREGNANCY TEST (K032563) | Bayer Healthcare, LLC | 2003-12-23 |