Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in
FDA device recall Z-2283-2020 · posted 2020-06-05 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
- Action taken
- On May 4, 2020, Siemens notified their customers that use the Fructosamine and Enzymatic Creatinine assays on the Atellica, ADVIA, and Dimension platforms of the potential for falsely depressed results in the presence of NAPQI. An Urgent Medical Device Correction Notice was sent to consignees in the US and an Urgent Field Safety Notice was sent to customers outside the US. The letter stated that the Limitations of the Procedure section of the Instructions for Use (IFU) will be updated with specific information related to the assay/platform. Customers were asked to complete and return the Effectiveness Check questionnaire attached to the letter within 30 days. In addition, customers were informed that field service personnel will be sent an Service Knowledge Base (SKB) describing the issue and instructing them how to deal with customer questions.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JFY
- Quantity affected
- 1488
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of North Carolina, California, Indiana, Florida, Ohio, Arizona, Massachusetts, New Jersey, New Hampshire, Illinois, Minnesot
- Date initiated
- 2020-05-04
- Date posted
- 2020-06-05
- Date terminated
- 2021-09-20
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVIA CHEMISTRY ENZYMATIC CREATININE_2 (K070727) | Siemens Medical Solutions Diagnostics | 2007-08-03 |