| | Class 2 Device Recall Alinity hq series |  |
| Date Initiated by Firm | June 14, 2024 |
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| Date Posted | August 16, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2681-2024 |
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| Recall Event ID |
94958 |
| 510(K)Number | K220031 |
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| Product Classification |
Counter, differential cell - Product Code GKZ
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| Product | Alinity hq Analyzer, REF: 09P68-01 |
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| Code Information |
UDI-DI: 380740138851. Software Versions: 5.7 (US) and 5.6 and below (OUS),
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HQ01105, HQ01108, HQ01113, HQ01114, HQ01116, HQ01118, HQ01119, HQ01120, HQ01121, HQ01155, HQ01156, HQ01157, HQ01158, HQ01159, HQ01160, HQ01161, HQ01162, HQ01165, HQ01167, HQ01168, HQ01169, HQ01170, HQ01171, HQ01172, HQ01173, HQ01174, HQ01175, HQ01177, HQ01180, HQ01181, HQ01183, HQ01187, HQ01188, HQ01190, HQ01196, HQ01231, HQ01233, HQ01236, HQ01237, HQ01244, HQ01246
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| FEI Number |
2919069
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Recalling Firm/
Manufacturer |
Abbott Laboratories
4551 Great America Pkwy
Santa Clara CA 95054-1208
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| For Additional Information Contact |
408-567-3313 |
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Manufacturer Reason
for Recall | 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts |
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FDA Determined
Cause 2 | Software design |
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| Action | On 6/14/24, correction notices were sent to consignees informing them of the following:
1) Issue 1:
Continue to follow the Alinity h-series Operations Manual to verify flagged results.
In addition, you must select one of the two options below depending on your laboratory workflow:
Option 1: Batch your CBC+DIFF+RETIC samples on an analyzer. Ensure a Background cycle is run prior to processing the next CBC+DIFF sample on that analyzer.
OR
Option 2: The MCHC for the laboratories are typically set between 31 36 g/dL. In the event your patient sample flags MCHC results greater than the reference range in your lab, rerun the sample and ensure the rerun does not immediately follow a CBC+DIFF+RETIC sample.
2) Issue 2:
The %B high limit is typically set by the Laboratory between 2 5%. In the event your patient sample %B results are greater than the laboratory established high limit, follow the guidelines of your laboratory to rerun the sample or perform a manual slide review. Continue to follow the Alinity h-series Operations Manual to verify flagged results.
3) Provide a copy of the accompanying Product Correction letter to the laboratory manager, supervisor or health professional responsible for the impacted product.
4) 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.
5) Retain this letter for your laboratory records.
6) Complete and return the Customer Reply Form via email to PMS@abbott.com
Your Abbott representative will be scheduling a mandatory upgrade of your Alinity hq Analyzer to install software versions(Country): 5.10 (US), 5.9 (Canada and South Korea), 5.8 (OUS except Canada and South Korea).
If you or any of the health care providers you serve have questions regarding this information, please contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week).
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| Quantity in Commerce | 816 |
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| Distribution | Worldwide - US Nationwide distribution in the states of NY, OK, NC and the countries of ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, Botswana, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, GREECE, HONDURAS, 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, UK, URUGUAY, 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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