Recall Z-1421-2020 ยท JGS Electrode, Ion Specific, Sodium
Siemens Healthcare Diagnostics, Inc.
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
| Date | Mar 2, 2020 (initiated Jan 12, 2020) |
| Status | Open, Classified |
| Reason | Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results. |
| Root cause | Under Investigation by firm |
| Action | The firm distributed Urgent Medical Device Correction letters to all affected customers on January 17, 2020. Customers were asked to check each Atellica CH 930 Analyzer in their laboratory as well as in their inventory for impacted cuvette lot numbers ending in "17" or "18" (6th and 7th digits). These devices must be purged from the customer's inventory. If the customer does not have enough cuvette segments of the unimpacted lot in their inventory, they may contact customer service. Detailed instructions were provided in the appendices to the customer letter. ***Updated 3/2/2020*** An updated |
| Quantity | 3559 |
| Distribution | Domestic distribution nationwide. Worldwide foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica Siemens Healthcare Diagnostics, Mar 9, 2017 |