Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 16, 2022
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cytocell Ltd. recalled Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome lo… - a moderate-severity action.
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome lo… was recalled by Cytocell Ltd. in March 16, 2022. Reason: individual components have been labelled with incorrect colours. The red and green colours are opposite to th…. Check the official notice for the remedy. Verify recall #Z-0741-2022 with the FDA Devices before acting.
The recall
Cytocell Ltd. issued this moderate-severity FDA Devices recall-individual components have been labelled with incorrect colours. The red and green colours are opposite to th….
- Moderate
- severity level
- Class II
- classification
- March 16, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0741-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0741-2022) was formally reported on March 16, 2022, with the manufacturer initiating the action on January 18, 2022. It is classified under Moderate severity (Class II), with a current status of Terminated. Cytocell Ltd. is listed as the recalling firm, operating out of Cambridge, N/A. Federal records list the affected scope as 19 kits.
The documented reason for this recall is: individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control pr… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
19 kits
Related Recalls
6
3 from same agency
Product description
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
Reason for recall
individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0741-2022 |
| Date reported | March 16, 2022 |
| Date initiated | January 18, 2022 |
| Recalling firm | Cytocell Ltd. |
| Firm location | Cambridge, N/A |
| Affected scope | 19 kits |
| Distribution | US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0741-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024. Recalled by Cytocell Ltd.. Units affected: 19 kits.
Why was this product recalled? ▼
individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 16, 2022. Severity: Moderate. Recall number: Z-0741-2022.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0741-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 16, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.