Z-1202-2019Class III

Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent

Name: Z-1202-2019 Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent
Creator: Cytocell Ltd.
Published: 2019-03-15
License: https://open.fda.gov/license/

Cytocell Limited / initiated 2019-03-15 / Terminated / root cause: labeling and UDI

FDA source

Cytocell Ltd. began a recall of Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent on 2019-03-15. FDA classified it as Class III and gives the reason as "There is an error in the chromomap included in the labeling for the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1202-2019
Classification: Class III
Status: Terminated
Initiated: 2019-03-15
Posted: 2019-04-19
Terminated: 2020-10-13
Recalling firm: Cytocell Limited
Product: Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Product code: MVU Reagents, Specific, Analyte
Reason for recall: There is an error in the chromomap included in the labeling for the product.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Urgent Medical Device Recall notification letters dated 3/15/19 were sent to customers.
Quantity in commerce: 19
Distribution: The products were distributed to the following US states: IL, TN.
Product codes and lots: Lot numbers: 056996 061156 062616 062808

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1202-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1202-2019	Class III	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-19

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)