Date Initiated by Firm | September 28, 2021 |
Create Date | October 16, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0124-2022 |
Recall Event ID |
88792 |
510(K)Number | K151792 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product | Atellica IM 1300 Analyzer, SMN 11066001 |
Code Information |
All units |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc 333 Coney St East Walpole MA 02032-1516
|
For Additional Information Contact | 508-668-5000 |
Manufacturer 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. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | On September 27, 2021, the firm initiated notifications to affected customers. Customer distribution included all customers located in a city at an altitude of 350 meters (1148 feet) or higher.
Customers were informed that 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 350
(m) or 1148 (ft) above sea level. The letters provide directions for mitigating the
potential for leakage.
If you have any questions, contact your local Siemens Healthineers technical support representative. |
Quantity in Commerce | 1193 |
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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database | 510(K)s with Product Code = JJE
|