Reported Aug 28, 2024 · Ongoing

Alinity hq Analyzer, REF: 09P68-01

Abbott Laboratories

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Abbott Laboratories · 4551 Great America Pkwy · Santa Clara, CA · 95054-1208

Is this the product you have?

  • Alinity hq Analyzer
  • REF09P68-01
Lot codes and dates
  • UDI-DI380740138851
  • Software Versions5.7 (US) and 5.6 and below (OUS)
  • Serial Numbers

    816 of 816 codes

    • 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
Amount recalled
816

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:57 PM UTC

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