Atellica IM 1600 Analyzer, SMN 11066000
Reported: October 27, 2021 Initiated: September 28, 2021 #Z-0125-2022
Product Description
Atellica IM 1600 Analyzer, SMN 11066000
Reason for Recall
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 1733
- Distribution
- Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
Atellica IM 1600 Analyzer, SMN 11066000. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 1733.
Why was this product recalled? ▼
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 27, 2021. Severity: Moderate. Recall number: Z-0125-2022.
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