PANTHER FUSION System
Medical device recall Z-0782-2024. Published in FDA’s Enforcement Report on Jan 31, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 31, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 31 states named
- 771 systems (of which 313 are potentially impacted) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is an integrated, fully automated, in vitro diagnostic (IVD) clinical multiplex test system. It is capable of performing nucleic acid based tests from sample processing through amplification, detection, and data reduction.
771 systems (of which 313 are potentially impacted), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Fusion System Part Number: ASY-09600 UDI Code: Pending Serial Numbers Panther / Fusion: 1010910036 2101000822 1010910056 2101000883 1010910064 2101000783 1010910075 2101000786 1010910111 2101000654 1010910171 2101000961 1010910195…
Every code shown here, 1,991 characters
Fusion System Part Number: ASY-09600 UDI Code: Pending Serial Numbers Panther / Fusion: 1010910036 2101000822 1010910056 2101000883 1010910064 2101000783 1010910075 2101000786 1010910111 2101000654 1010910171 2101000961 1010910195 2101000810 1010910216 2101000866 1010910220 2101000500 1010910343 2101000779 1010910389 2101000901 1010910453 2101000900 1010910461 2101000675 1010910470 2101000645 1010910504 2101000674 1010910544 2101000703 1010910551 2101001001 1010910571 2101000837 1010910647 2101000893 1010910649 2101000712 1010910672 2101000760 1010910686 2101000979 1010910690 2101000775 1010910691 2101000778 1010910716 2101000845 1010910731 2101000827 1010910732 2101000831 1010910733 2101000807 1010910789 2101000858 1010910790 2101000859 1010910795 2101000879 1010910821 2101000894 1010910824 2101000916 1010910825 2101000917 1010910826 2101000919 1010910837 2101000846 1010910856 2101000939 1010910877 2101000947 2090000355 2101000218 2090000527 2101000791 2090000585 2102100927 2090000617 2101000355 2090000747 2101000655 2090000798 2101000344 2090000896 2101000885 2090000902 2101000918 2090000909 2101000236 2090000959 2101000414 2090000996 2101000334 2090001017 2101000834 2090001099 2101000079 2090001309 2101000083 2090001393 2101000214 2090001410 2101000119 2090001424 2101000324 2090001550 2101000889 2090001556 2101000973 2090001591 2101000075 2090001656 2101000860 2090001700 2101000902 2090001740 2101000888 2090001780 2101000994 2090001786 2101000139 2090001860 2101000577 2090001871 2101000616 2090001872 2101000173 2090001886 2101000310 2090002308 2101001008 2090002339 2101000128 2090002341 2101000376 2090002447 2101000374 2090002462 2101000777 2090002487 2101000459 2090002530 2101000785 2090002551 2101000231 2090002572 2101000136 2090002692 2101000273 2090002730 2101000342 2090002742 2101000312 2090002768 2101000833 2090002798 2101000118 2090002810 2101000895 2090002824 2101000248 2090002847 2101000225 2090002911 2101000773 2090002964 2101000252 2090002969…
FDA’s list runs to 3,057 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - U.S. Nationwide distribution including in the states of AK, AR, CA, CO, CT, FL, IL, IN, MA, ME, MI, MN, MO, MT, NC, ND, NH, NJ, NM, NV, NY, OH, PA, Puerto Rico, TX, UT, VA, VI, WA, WI, and WV. The countries of Austria, Australia, Belgium, Dominican Republic, Switzerland, Germany, Denmark, Spain, France, Great Britain, Hong Kong, Ireland, Italy, Korea, Kuwait, The Netherlands, Norway, New Zealand, Portugal, Qatar, and Sweden.
The states and territories these words name
31 states and territories.
Every one of them
- Alaska
- Arkansas
- California
- Colorado
- Connecticut
- Florida
- Illinois
- Indiana
- Massachusetts
- Maine
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- North Dakota
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Pennsylvania
- Puerto Rico
- Texas
- Utah
- Virginia
- US Virgin Islands
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 15, 2023.
- FDA classified it on Jan 23, 2024.
- FDA’s Enforcement Report published it on Jan 31, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Hologic, Inc., of San Diego, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,057 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.