Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb r
FDA device recall Z-1843-2019 · posted 2019-06-19 · Terminated
Recall details
- Recalling firm
- Cytocell Ltd.
- Reason for recall
- There is an error in the chromomap on the package insert.
- Action taken
- Urgent Medical Device Recall letters were distributed to customers beginning 4/26/19.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- MVU
- Quantity affected
- 400
- Distribution
- Worldwide Distribution - US Nationwide AL, CO, FL, HI, IA, IL, IN, KY, MA, MD, MI, MO, MS, NC, NJ, NY, TN, TX, UT, WA, and WI. The products were distributed to the following foreign countries: Canada.
- Date initiated
- 2019-04-26
- Date posted
- 2019-06-19
- Date terminated
- 2020-07-16
- Location
- Cambridge, United Kingdom
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