CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Reported: May 14, 2014 Initiated: February 26, 2013 #Z-1545-2014
Product Description
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Reason for Recall
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics Inc
- Units Affected
- 1 unit
- Distribution
- US Distribution in the state of: CA.
- Location
- Norwood, MA
Frequently Asked Questions
What product was recalled? ▼
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 1 unit.
Why was this product recalled? ▼
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 14, 2014. Severity: Low. Recall number: Z-1545-2014.
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