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Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
| Product or model | Codes and lots | Quantity | Recall number |
|---|---|---|---|
| Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. | Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers. | 24,077 units | Z-2703-2026 |
The agency's statement is shown without a site-authored severity score.
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
Agency classification: Class II
Only instructions associated with this recall event qualify as an action.
Consumer action is not available in the associated official record. The site does not infer or generate a replacement.
The linked agency record controls if any information differs.
Official scope
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bangladesh, Bolivia, Brazil, Bulgaria, Burkina¿Faso, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Democratic Republic Congo, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Poland, Portugal, Qatar, Republic of Korea, Romania, Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Thailand, Turkey, Turkmenistan, U.A.E., Uganda, United¿Kingdom, Uruguay, Vatican City, Vietnam.
Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.
No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.
