Recall Z-0636-2013 ยท JJW Urinalysis Controls (Assayed And Unassayed)
Siemens Healthcare Diagnostics Inc
Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS Automated urine Chemistry Analyzer and CLINITEK ATLAS 10 reagent Pak, CLINITEK ATLAS Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen,
| Date | Jan 4, 2013 (initiated Nov 21, 2012) |
| Status | Terminated |
| Reason | When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F). |
| Root cause | Nonconforming Material/Component |
| Action | Siemens issued An Urgent Field Safety Notice via e-mail to all affected SiemensHealthcare Diagnostics Regional offices on November 21, 2012 both in the United States and foreign accounts. This notice informed customers of the issue with the CLINITEK Atlas and Chek-Stix Positive Urinalysis Control Solutions When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F). You can use the reconstituted positive control solution for up to eight hours if the solution is held at |
| Quantity | 6466 |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943780 | NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) Heraeus Kulzer, Inc., Oct 31, 1994 |