Atellica CH Enzymatic Hemoglobin A1c recall
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Why was Atellica CH Enzymatic Hemoglobin A1c recalled?
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00630414220505; Lot Numbers: 110027 110060 110065 110091 110113 110129 110137 110161 110170 110208 110224 110234 110235 110262 110265 110273 110286 110315 110330 110347 110360
- Product
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 6606
- Distribution
- Global Distribution. US Nationwide.
- Recall date
- April 20, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)