| | Class 2 Device Recall Alinity hq Analyzer |  |
| Date Initiated by Firm | September 18, 2025 |
|---|
| Date Posted | November 12, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0489-2026 |
|---|
| Recall Event ID |
97788 |
| 510(K)Number | K220031 K243283 |
|---|
| Product Classification |
Counter, differential cell - Product Code GKZ
|
| Product | Brand Name: Alinity hq Analyzer
Product Name: Alinity hq Analyzer
Model/Catalog Number: 09P68-01
Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US
Product Description: Alinity hq Analyzer
Component: No |
|---|
| Code Information |
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|
Recalling Firm/
Manufacturer |
Abbott Laboratories
4551 Great America Pkwy
Santa Clara CA 95054-1208
|
| For Additional Information Contact | Suchin Song
408-567-3313 |
|---|
Manufacturer Reason
for Recall | Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results. |
|---|
FDA Determined
Cause 2 | Software design |
|---|
| Action | On September 18, 2025, Abbott Laboratories issued an "Urgent Medical Device Recall" Notification. Abbott ask consignees to take the following actions:
1. If IG/%IG is above your laboratory established reference range (e.g. greater than 2%), review the results per your laboratory procedures. A manual smear review may need to be performed to confirm the results.
2. Complete and return the Customer Reply Form.
3. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter.
4. Please retain this letter for your laboratory records.
If the problem persists, contact your Abbott representative or Abbott Technical Support
(1-800-727-7846) for help to determine whether the inability to communicate is related to this issue. |
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| Quantity in Commerce | 833 |
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| Distribution | Worldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN, NC, NY, OK and OUS (foreign) to countries of: ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MALDIVES, MEXICO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SERBIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE,UNITED KINGDOM, URUGUAY, and VIETNAM.
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = GKZ
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