Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 22, 2019
Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)Beta-D Glucan, a major cell wall component of various medically important fungi, can be used as an aid in teh diagnosis of deep-seated mycoses and funemias. A positve result does not i
The kits may contain the incorrect number of components or the kits may be missing components.
Associates of Cape Cod, Inc. recalled Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-ba… - a moderate-severity action.
Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-ba… was recalled by Associates of Cape Cod, Inc. in May 22, 2019. Reason: The kits may contain the incorrect number of components or the kits may be missing components.. Check the official notice for the remedy. Verify recall #Z-1329-2019 with the FDA Devices before acting.
The recall
Associates of Cape Cod, Inc. issued this moderate-severity FDA Devices recall-The kits may contain the incorrect number of components or the kits may be missing components..
- Moderate
- severity level
- 795 units
- affected scope
- Class II
- classification
- May 22, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1329-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1329-2019) was formally reported on May 22, 2019, with the manufacturer initiating the action on December 19, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Associates of Cape Cod, Inc. is listed as the recalling firm, operating out of East Falmouth, MA. Federal records list the affected scope as 795.
The documented reason for this recall is: The kits may contain the incorrect number of components or the kits may be missing components. Distribution data in the federal record shows the product reached: Worldwide distribution - US nationwide in the states of CA, FL, MD, UT, VA and countries of Singapore, South Africa, United Kingdo.m. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
795
Related Recalls
6
6 from same agency
Product description
Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)Beta-D Glucan, a major cell wall component of various medically important fungi, can be used as an aid in teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.
Reason for recall
The kits may contain the incorrect number of components or the kits may be missing components.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1329-2019 |
| Date reported | May 22, 2019 |
| Date initiated | December 19, 2018 |
| Recalling firm | Associates of Cape Cod, Inc. |
| Firm location | East Falmouth, MA |
| Affected scope | 795 |
| Distribution | Worldwide distribution - US nationwide in the states of CA, FL, MD, UT, VA and countries of Singapore, South Africa, United Kingdo.m |
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-1329-2019) 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? ▼
Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)Beta-D Glucan, a major cell wall component of various medically important fungi, can be used as an aid in teh diagnosis of deep-seated mycoses and funemias. A positve result does not indicate which genus of fungi may be causing the infection. (1-3)Beta-D Glucan titers should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.. Recalled by Associates of Cape Cod, Inc.. Units affected: 795.
Why was this product recalled? ▼
The kits may contain the incorrect number of components or the kits may be missing components.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2019. Severity: Moderate. Recall number: Z-1329-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US nationwide in the states of CA, FL, MD, UT, VA and countries of Singapore, South Africa, United Kingdo.m.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1329-2019) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
FDA Devices Moderate
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Mate…
Boston Scientific Corporation · 2026-07-29
FDA Devices Moderate
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathe…
Boston Scientific Corporation · 2026-07-29
FDA Devices Moderate
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
AVID Medical, Inc. · 2026-07-29
FDA Devices Moderate
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Penumbra, Inc. · 2026-07-29
FDA Devices Moderate
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Alphatec Spine, Inc. · 2026-07-29
Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
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 May 22, 2019. 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 August 2026.