Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / quali
FDA device recall Z-1116-2012 · posted 2012-02-28 · Terminated
Recall details
- Recalling firm
- PerkinElmer Life and Analytical Sciences, Wallac, OY
- Reason for recall
- GSP instruments with defective washer modules may cause a false negative screening result being reported for T4, TSH and IRT. For 17-OHP, a false positive result may be generated if the failure occurs for a normal sample.
- Action taken
- Perkin Elmer issued an "Urgent Medical Device Recall" letter dated 1/25/12 to all customers and informed them about the possible issue and requested permission for service personnel to check their instrument. The customers were instructed that the instrument could not be used and the washer module required replacement. Customers were told to expect to be contacted by the firm's local representative for further details.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KHO
- Quantity affected
- 10 units
- Distribution
- Worldwide Distribution - USA, including the states of Florida, Ohio, Oregon, Texas and the countries of Brazil, Belgium, France, Germany, and the UK.
- Date initiated
- 2012-01-09
- Date posted
- 2012-02-28
- Date terminated
- 2013-03-06
- Location
- Turku, Finland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GSP INSTRUMENT AND GSP NEONATAL HTSH KIT (K090846) | Perkinelmer, Inc. | 2009-09-03 |