Reported Nov 8, 2023 · Ongoing
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Randox Laboratories Ltd.
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: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North), N/A · N/A
Is this the product you have?
- RX Imola-IVD Clinical
- Chemistry Analyzer Catalog NumberRX4900. RX4900R (refurbished)
- Lot codes and dates
- GTIN05055273206104
- Lot/Batch Number(1)(2)¿¿¿¿¿¿¿¿¿¿¿¿¿ 7201-0776 7201-0367 7201-0343¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿ 7201-0348 ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿
7201-07477201-04237201-04177201-03537255-01987255-01727255-01717255-01297201-10857201-10867201-10797201-10807201-09827201-09777201-09707201-09507201-09247201-09197201-09017201-08497201-08277201-08017201-07687201-06067201-05627201-05357201-05317201-0482
- Amount recalled
- 35 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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