EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measur
FDA device recall Z-0697-2016 · posted 2016-01-28 · Terminated
Recall details
- Recalling firm
- Phadia Ab
- Reason for recall
- All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies.
- Action taken
- On 12/28/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions call 1-800-3464364, option #2.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LKP
- Quantity affected
- 76
- Distribution
- US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.
- Date initiated
- 2015-12-28
- Date posted
- 2016-01-28
- Date terminated
- 2016-08-16
- Location
- Uppsala, Sweden
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EIA SMDP IMMUNOASSAY (K132631) | Phadia US, Inc. | 2014-08-29 |