510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-2681-2024Class II

Alinity hq Analyzer, REF: 09P68-01

Abbott Medical / initiated 2024-06-14 / Open, Classified / root cause: software
FDA source (opens on fda.gov)

Abbott Laboratories began a recall of Alinity hq Analyzer, REF: 09P68-01 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number
Z-2681-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Abbott Medical
Product
Alinity hq Analyzer, REF: 09P68-01
Product code
GKZ Counter, Differential Cell
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
Root cause tag
software
FDA root cause
Software design
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 [email protected] 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).
Quantity in commerce
816
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.
Product codes and lots
UDI-DI: 380740138851. Software Versions: 5.7 (US) and 5.6 and below (OUS), Serial Numbers: HQ00105, HQ00108, HQ00117, HQ00118, HQ00119, HQ00120, HQ00126, HQ00127, HQ00128, HQ00132, HQ00136, HQ00139, HQ00140, HQ00141, HQ00142, HQ00144, HQ00145, HQ00147, HQ00148, HQ00149, HQ00152, HQ00153, HQ00154, HQ00156, HQ00157, HQ00161, HQ00162, HQ00166, HQ00169, HQ00171, HQ00172, HQ00173, HQ00174, HQ00175, HQ00183, HQ00184, HQ00185, HQ00186, HQ00187, HQ00188, HQ00266, HQ00268, HQ00269, HQ00270, HQ00271, HQ00273, HQ00274, HQ00276, HQ00277, HQ00278, HQ00279, HQ00281, HQ00282, HQ00283, HQ00286, HQ00287, HQ00289, HQ00291, HQ00295, HQ00296, HQ00299, HQ00300, HQ00302, HQ00303, HQ00312, HQ00313, HQ00314, HQ00316, HQ00318, HQ00319, HQ00321, HQ00324, HQ00327, HQ00328, HQ00329, HQ00331, HQ00332, HQ00334, HQ00335, HQ00336, HQ00337, HQ00338, HQ00417, HQ00418, HQ00419, HQ00420, HQ00422, HQ00424, HQ00425, HQ00430, HQ00432, HQ00433, HQ00434, HQ00435, HQ00436, HQ00438, HQ00439, HQ00440, HQ00441, HQ00442, HQ00443, HQ00444, HQ00445, 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Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2681-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2681-2024Class IIOngoingVoluntary: Firm initiated